【正文】 常 用 藥 品 監(jiān) 管 英 語 與 縮 略 語 一、監(jiān)管英語1.《中華人民共和國藥品管理法》 Drug Control Law of the People39。s Republic of China control over drug manufacturers control over drug distributors control over medicines in medical institutions control over drugs control over drug packaging control over drug price and advertisement inspection of drugs legal liabilitieslabels or marks of the drugscounterfeit drugsinferior drugsdrug quality control laboratorydrug manufacturersdrug distributorsmedical institutionsdrug regulatory agencydrug approval documentsadministrative sanctionscriminal liabilities Good Manufacturing Practice for Pharmaceutical Products (GMP)Good Supply Practice for Pharmaceutical Products (GSP)Drug Manufacturing CertificateDrug Supply CertificatePharmaceutical Preparation Certificate for Medical InstitutionImport Drug Licenseclinical trialNew Drug CertificateDrug Approval Number、生產(chǎn)、經(jīng)營、使用和監(jiān)督管理的單位或者個人，必須遵守《中華人民共和國藥品管理法》 All institutions or individuals engaged in research, production,distribution, use, and administration and supervision of drugs in thePeople39。s Republic of China shall abide by drug control law of the people39。srepublic of China.。The drug regulatory agency of the State Council shall be responsible fordrug administration and supervision nationwide. 、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。 The drug regulatory agencies of the governments of provinces, autonomousregions, and municipalities directly under the Central Government shall beresponsible for drug regulation in their administrative areas. ，承擔(dān)依法實(shí)施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗(yàn)工作。 The drug quality control laboratories established or designated by drugregulatory agencies shall undertake the responsibility for drug testingrequired for conducting drug review and approval and controlling drugquality pursuant to the law.，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品生產(chǎn)許可證》，憑《藥品生產(chǎn)許可證》到工商行政管理部門辦理登記注冊。Any newly established pharmaceutical manufacturer shall be subject toapproval by the local drug regulatory agency of the government of theprovince, autonomous region or municipality directly under the CentralGovernment and be granted the Drug Manufacturing Certificate, and, with thecertificate, the manufacturer shall be registered with the administrativeagency for industry and merce.35.《藥品生產(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。 The term of validation and the scope of manufacturing shall be noted in theDrug Manufacturing Certificate. For renewal of the certificate onexpiration, reviewing and approval again is required.，應(yīng)當(dāng)符合國家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。 When giving approval to the newlyestablished manufacturer, the drugregulatory agency shall see to it that the development programs and policiesset by the State for the pharmaceutical industry shall be plied with soas to prevent duplicate construction.，必須具備以下條件：（一）具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人；（二）具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境；（三）具有能對所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備；（四）具有保證藥品質(zhì)量的規(guī)章制度。 Any drug manufacturer to be established shall meet the followingrequirements: (1) stuffed with legally qualified pharmaceutical andengineering professionals and the necessary technical workers。(2) providedwith the premises, facilities, and clear environment required for drugmanufacturing。 (3) having quality management and control units and personnelcapable of quality management of and testing for drugs to be produced andthe necessary instruments and equipment。 and (4) establishing rules andregulations to govern the quality of drugs.《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)。藥品監(jiān)督管理部門按照規(guī)定對藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對認(rèn)證合格的，發(fā)給認(rèn)證證書。 Drug manufacturers shall conduct production according to the GoodManufacturing Practice Products (GMP) formulated by the drug regulatoryagency of the State Council based on this Law. The drug regulatory agencyshall inspect a drug manufacturer as to its pliance with the GMPrequirements and issue a certificate to the manufacturer passing theinspection.，藥品必須按照國家藥品標(biāo)準(zhǔn)和國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。 With the exception of the processing of prepared slices of Chinese crudedrugs, a drug shall be produced in conformity with the National DrugStandard and with the production processes approved by the drugregulatory agency of the State Council, and the production records shall beplete and accurate. ，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。When drug manufacturers make any change in the production process that mayaffect the drug quality, they shall submit the change to the originalauthority for reviewing and approval.、輔料，必須符合藥用要求。 Active pharmaceutical ingredients (API) and recipients for the manufactureof pharmaceutical products shall meet the requirements for medicinal use.。Drug manufacturers shall perform quality test of their products.、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的，不得出廠。 No products that do not meet the National Drug Standards or that are notproduced according to the processing procedures for the prepared slices ofChinese crude drugs formulated by the drug regulatory agency of thegovernment of a province, autonomous region, or municipality directly underthe Central Government may be released.、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。 A drug manufacturer may not accept any contract production of drugs unlessit is approved by the drug regulatory agency of the State Council, or by thedrug regulatory agency of the government of a province, autonomous region,or municipality directly under the Central Government authorized by the drugregulatory agency of the State Council.，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營許可證》.Any newly established drug wholesaler shall be subject to approval of thelocal drug agency of the government of the province, autonomous region ormunicipality